Pirfenidone

Generic Name: Pirfenidone

Brand Names: Esbriet, Pirfenidone axunio (previously Pirfenidone AET), Pirfenidone Viatris

Drug Type: Small Molecule

Chemical Formula: C_₁₂H_₁₁NO

CAS Number: 53179-13-8

Unique Ingredient Identifier: D7NLD2JX7U

Background: Pirfenidone is a synthetic pyridone drug. It is an antifibrotic agent with anti-inflammatory and antioxidant properties that is used to treat idiopathic pulmonary fibrosis (IPF), which is a chronic, progressive form of interstitial pneumonia. While its mechanism of action is not yet fully understood, pirfenidone is proposed to primarily regulate tumor necro...

Indication: Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). In Canada and Europe, it is approved in adults only.

Associated Conditions: Idiopathic Pulmonary Fibrosis (IPF), Mild Idiopathic Pulmonary Fibrosis, Moderate Idiopathic Pulmonary Fibrosis

Associated Therapies: -

Clinical Trials

Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury

Phase 2

Conditions: Radiation Pneumonitis

Interventions: Drug: Pirfenidone

First Posted Date: 2014-11-20

Last Posted Date: 2014-11-20

Lead Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

Target Recruit Count: 48

Registration Number: NCT02296281

European Trial of Pirfenidone in BOS, A European Multi-center Study

Phase 2

Completed

Conditions: Disorder Related to Lung Transplantation
CLAD, Bronchiolitis Obliterans

Interventions: Drug: Placebo
Drug: Pirfenidone

First Posted Date: 2014-10-13

Last Posted Date: 2020-01-18

Lead Sponsor: Rigshospitalet, Denmark

Target Recruit Count: 90

Registration Number: NCT02262299

Locations: 🇳🇱
Groningen University Medical Center, Lung Transplant Team, Groningen, Netherlands
🇩🇪
Medizinische Hochschule Hannover, Klinik für Pneumonologie, Hannover, Germany
🇩🇪
Klinikum Grosshadern, Division of Pulmonary Diseases, Munich, Germany

and more 6 locations

Effect of Topic Pirfenidone in Diabetic Ulcers

Phase 3

Completed

Conditions: Diabetic Foot Ulcers

Interventions: Procedure: Debridement
Drug: Pirfenidone

First Posted Date: 2014-08-21

Last Posted Date: 2016-02-15

Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Target Recruit Count: 36

Registration Number: NCT02222376

Locations: 🇲🇽
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Distrito Federal, Mexico

Pirfenidone, an Antifibrotic and Antiinflammatory Drug

Phase 2

Completed

Conditions: Fibrosis
Hepatitis C Chronic

Interventions: Drug: Pirfenidone
Drug: Matched equivalent placebo

First Posted Date: 2014-06-12

Last Posted Date: 2014-07-09

Lead Sponsor: University of Guadalajara

Target Recruit Count: 150

Registration Number: NCT02161952

Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone

Conditions: Idiopathic Pulmonary Fibrosis

First Posted Date: 2014-05-19

Last Posted Date: 2015-07-13

Lead Sponsor: Genentech, Inc.

Registration Number: NCT02141087

Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

Phase 2

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Pirfenidone
Drug: placebo

First Posted Date: 2014-05-13

Last Posted Date: 2014-05-13

Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Target Recruit Count: 160

Registration Number: NCT02136992

Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)

Phase 2

Completed

Conditions: Systemic Sclerosis

Interventions: Drug: Pirfenidone

First Posted Date: 2013-09-02

Last Posted Date: 2016-08-04

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 63

Registration Number: NCT01933334

Locations: 🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States
🇺🇸
University of California, Los Angeles, Los Angeles, California, United States
🇺🇸
Northwestern University, Chicago, Chicago, Illinois, United States

and more 19 locations

A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Lebrikizumab
Drug: Pirfenidone
Drug: Placebo

First Posted Date: 2013-06-07

Last Posted Date: 2018-08-24

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 505

Registration Number: NCT01872689

Locations: 🇺🇸
Pulmonary Consultants, Tacoma, Washington, United States
🇦🇺
Box Hill Hospital; Eastern Clinical Research Unit, Box Hill, Victoria, Australia
🇫🇷
Hopital Bichat Claude Bernard ; Service de Pneumologie, Paris, France

and more 109 locations

Safety and Efficacy Study of Pirfenidone to Treat Idiopathic Pulmonary Fibrosis(IPF)

Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Placebo
Drug: Pirfenidone

First Posted Date: 2012-01-05

Last Posted Date: 2012-02-07

Lead Sponsor: Beijing Kawin Technology Share-Holding Co., Ltd.

Target Recruit Count: 80

Registration Number: NCT01504334

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijng, China

Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Phase 3

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Placebo
Drug: Pirfenidone

First Posted Date: 2011-06-03

Last Posted Date: 2017-04-05

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 555

Registration Number: NCT01366209

Locations: 🇺🇸
InterMune Inc., Brisbane, California, United States

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